The new Medtronic Valiant Navion TEVAR device: How this
new low-profile device can impact TEVAR
Prof. Fabio Verzini, MD, PhD, FEBVS
University of Perugia, Italy
Disclosure
Speaker name:
...............Fabio Verzini...............................................
I have the following potential conflicts of interest to report:
Consulting for Cook, Gore, Medtronic
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
Proximal configuration with tip capture
Low Profile Design
Multi-filament (same as Endurant) vs. Mono-filament Valiant graft material
Minimized profile
up to 4 Fr reduction in profile
24 Fr25 Fr 22 Fr
46-40mm 37-28mm 25-20mm
Valiant Captivia
Valiant Navion 18 Fr22 Fr 20 Fr
Broad size matrix
• Treat wide range of anatomies
– Increased length (225 mm)
– Smaller diameter (20mm)
– Refined tapering (5 & 6 mm)
• Tailored pieces for specific use (increased tapering, cuff, sizing changes)
FrSG Size (mm)
Covered Length (mm)*
60 100 175 225
20 x
22 x x
25 x x
28 x x
31 x x x
34 x x x x
37 x x x x
40 x x x x
43 x x x x
46 x x x x
18 Fr
22 Fr
20 Fr
DELIVERY SYSTEM MODIFICATIONS VS. VALIANT CAPTIVIA
Tapered Tip
– Length reduced by ~1cm versus Valiant Captivia system (22Fr)
– Length proportionally sized to maintain taper
Working Length and Hydrophilic coating Length
– Working length increase: 10cm
• Valiant Captivia WL = 83cm;
• Navion WL = 93cm
– Hydrophilic coating length increase: ~10cm
• Valiant Captivia HCL ~ 70cm;
• Navion HCL ≥ 80cm
18Fr –
23.3mm
20Fr –
25.6mm
22Fr –
27.9mm
Valiant
Captiva22Fr – 37.9mm
Length
Working Length = 93cm
Hydrophilic Coating
Length ≥ 80cm
FreeFloCoveredSeal
Stent graft design overview
Valiant EVO Global clinical trial
Design
• Prospective, multi-center, pre-
market, non-randomized, single-arm
trial
Enrollment
• 37 sites worldwide In North America &
EU
• 100 subjects
• First patient in: April 2016
Endpoints
• Safety: Major Adverse Events
(MAEs) within 30-days post-
implantation
• Effectiveness: Technical success at
index procedure and treatment
success at 12-months]
US (22 Centers)
PI: Prof. A. Azizzadeh
OUS (15 Centers)
PI: Prof. F. Verzini
• Female, 83 y.o.
• Hypertension
• Hypercholesterolemia
• Type 2 diabetes mellitus
• Persistent atrial fibrillation under anticoagulantand antiarrhytmic therapy
• COPD
Persistent coughing and dysphonia
Left vocal cord paralysis
Distal aortic arch penetrating aortic ulcer
Prcutaneous
Left brachial
access
Right femoral surgical
cut-down
Percutaneous left
femoral access
right common vein
access for
Cardiac rapid
pacing
1 stage: L carotid-subclavian bypass,2 stage: TEVAR w Rapid pacing
Navion FreeFlo 34-28-175
Prevertebral subclavian embolization
Amplatzer Vascular Plug II 10 mm
Post-procedural
angiogram
30 days post-op CTA
• Male, 59 y.o.
• Hypertension
• Hypercholesterolemia
• Type 2 diabetes mellitus
• Obesity
• COPD
• Renal Insufficiency
• 6 cm Thoracic Aneurysm
Navion40-40-175 FreeFlo+
43-43-175 CoveredSeal
Right femoral
surgical
cut-down
Left percutaneous fem:
• vein access for
Cardiac rapid pacing
• Artery for Angio
1 stage: L carotid-subclavian bypass, Amplatzer LSA embolization
2 stage: TEVAR w Rapid pacing
Conclusion
• New, Low Profile Navion, based on the solid design of the Valiant device, offers multiple options in size and 2 different prox graft-configurations
• In trial
• Results expected soon
The new Medtronic Valiant Navion TEVAR device: How this
new low-profile device can impact TEVAR
Prof. Fabio Verzini, MD, PhD, FEBVS
University of Perugia, Italy
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